[Federal Register Volume 62, Number 151 (Wednesday, August 6, 1997)]
[Notices]
[Pages 42256-42257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20633]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 95N-0309]


Agency Information Collection Activities: Proposed Collection; 
Extension

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
regarding the manufacture of infant formula, including infant formula 
labeling, quality control procedures, notification requirements, and 
recordkeeping.

DATES: Submit written comments on the collection of information by 
October 6, 1997.
ADDRESSES:  Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1223.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests

[[Page 42257]]

or requirements that members of the public submit reports, keep 
records, or provide information to a third party. Section 3506(c)(2)(A) 
of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to 
provide a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
of an existing collection of information, before submitting the 
collection to OMB for approval. To comply with this requirement, FDA is 
publishing notice of the proposed collection of information listed 
below.
     With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

 Infant Formula Requirements (21 CFR 106.100, 21 CFR 106.120(b), 21 
CFR 107.10(a), 21 CFR 107.20, 21 CFR 107.50(e)(2), 21 CFR 
107.50(b)(3), 21 CFR 107.50(b)(4), 21 CFR 107.50(c)(3))--(OMB 
Control Number 0910-0256)--Extension

    Statutory requirements for infant formula under the Federal Food, 
Drug, and Cosmetic Act (the act) are strict to protect the health of 
infants and include a number of reporting and recordkeeping 
requirements. Among other things, section 412 of the act (21 U.S.C. 
350a) requires manufacturers of infant formula to establish and adhere 
to quality control procedures, notify FDA when a batch of infant 
formula that has left the manufacturer's control may be adulterated or 
misbranded, and keep records of distribution. FDA has issued 
regulations to implement the act's requirements for infant formula in 
21 CFR parts 106 and 107.
    FDA also regulates the labeling of infant formula under the 
authority of section 403 (21 U.S.C. 343). Under the labeling 
regulations for infant formula in 21 CFR part 107, the label of an 
infant formula must include nutrient information and directions for 
use. The purpose of these labeling requirements is to ensure that 
consumers have the information they need to prepare and use infant 
formula appropriately.
    In a notice published in the Federal Register of July 9, 1996 (61 
FR 36154), FDA proposed changes in the infant formula regulations, 
including some of those listed below. The notice included revised 
burden estimates for the proposed changes and solicited public comment. 
In the interim, however, FDA is seeking an extension of OMB approval 
for the current regulations so that it can continue to collect 
information while the proposal is pending.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden                                  
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
106.120(b)                              4               7              28              10             280       
107.10(a)                                                                                                       
107.20                                                                                                          
107.50(b)(3),(b)(4)                     3               4              12               5              60       
107.50(e)(2)                                                                                                    
Total                                                                                                 340       
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There are no capital costs or operating and maintenance costs associated with this collection.                  


                                 Table 2.--Estimated Annual Recordkeeping Burden                                
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
106.100                                 4              10              40           7,980          31,920       
107.50(c)(3)                                                                                                    
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There are no capital costs or operating and maintenance costs associated with this collection.                  

     In compiling these estimates, FDA consulted its records of the 
number of infant formula submissions received in the past. The figures 
for hours per response are based on estimates from experienced persons 
in the agency and in industry. Because these infant formula regulations 
implement statutory information collection requirements, only the 
additional burden attributable to the regulations has been included in 
the estimates.

    Dated: July 30, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-20633 Filed 8-5-97; 8:45 am]
BILLING CODE 4160-01-Fst